O-3

Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

Miscellaneous

Intravenous Fat Emulsion is a preparation of 10% refined soyabean oil intended to be used as an intravenous nutrient. Intravenous fat emulsion prevents Essential Fatty Acid Deficiency (EFAD) and corrects the clinical manifestations of EFAD. However, for patients requiring complete parenteral nutrition, complementary vitamin supplements are required. Intravenous Fat Emulsion are prepared from either soyabean or safflower oil and provide a mixture of neutral triglycerides, predominantly unsaturated fatty acids. The major components of fatty acids are linoleic, oleic, palmitic acids. In addition, Fatisol contains 1.2% egg yolk phospholipids as an emulsifier and glycerol to adjust tonicity. IV Fat emulsions are isotonic and may be given by central or peripheral venous route. Fatisol is formulated as a concentrated source of energy to be used together with carbohydrates and amino acids in parenteral nutrition, it is isotonic, and provides a source of basal phosphate requirements and a source of vitamin E.

For infusion into a central or peripheral vein. ? May be infused directly from the bottle or admixed in a parenteral nutrition (PN) container. ? Prior to administration,correct severe fluid and electrolyte disorders and measure serum triglycerides to establish a baseline level. ? Initiate dosing in PN-dependent pediatric patients as soon as direct or conjugated bilirubin levels are 2 mg/dL or greater. ? Recommended dosage depends on age,energy expenditure,clinical status,body weight,tolerance,ability to metabolize,and consideration of additional energy sources given to the patient. ? The recommended daily dose (and the maximum dose) in pediatric patients is 1 g/kg/day. ? For information on infusion rate when initiating dosing and in patients with elevated triglyceride levels,see the full prescribing information. ? The recommended duration for infusion is between 8 and 24 hours, depending on the clinical situation. ? Administer Omegaven until direct or conjugated bilirubin levels are less than 2 mg/dL or until the patient no longer requires PN.

Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only limited clinical importance. Heparin in clinical doses causes a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.

Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients. ? Severe hemorrhagic disorders. ? Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides greater than 1,000 mg/dL. ? Risk of Death in Preterm Infants due to Pulmonary Lipid Accumulation: Deaths in preterm infants after infusion of intravenous soybean oil-based lipid emulsions have been reported in literature,and autopsy findings included intravascular fat accumulation in the lungs. Risk with Omegaven is unknown. Monitor for signs and symptoms of pleural or pericardial effusion. ? Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reaction occurs. ? Risk of Infections,Fat Overload Syndrome,Refeeding Syndrome,and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters. ? Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. ? Monitoring and Laboratory Tests: Routine laboratory monitoring is recommended,including monitoring for essential fatty acid deficiency

vomiting,agitation, bradycardia,apnea and viral infection.

Pregnancy Risk Summary There are no available data on Omegaven use in pregnant women to establish a drug-associated risk of major birth defects,miscarriage,or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with fish oil triglycerides. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect,loss,or other adverse outcomes. In the US general population,the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,respectively. Lactation Risk Summary No data are available regarding the presence of fish oil triglycerides from Omegaven in human milk,the effects on the breastfed infant,or the effects on milk production. Lactating women receiving oral omega-3 fatty acids have been shown to have higher levels of 11 omega-3 fatty acids in their milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Omegaven,and any potential adverse effects of Omegaven on the breastfed infant.

Impaired capacity to eliminate this may lead to fat overload syndrome as a result of overdosage. It may also occur at recommended rates of infusion in association with a sudden change in the clinical condition such as renal function impairment or infection. Fat overload syndrome is characterised by bone marrow depression, anaemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipaemia, fever, fat infiltration, focal seizures and shock. All symptoms are usually reversible if the infusion of this is discontinued.

Store at 15°C to 30°C in a dry place protected from light. Keep out of reach of children. Do not use if there is evidence of excessive creaming or aggregation, if excessive free oil droplets are visible, if the bag is leaking or if the bottle is damaged, solution is frozen, discolored or contains particles. The left over contents of opened bag or bottles should be discarded & not saved for later use. This contains no preservatives.

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Each 100 ml contains- Refined Soyabean Oil BP 10 gm Purified Egg Lecithin Ph. Gr. 1.2 gm Glycerol BP 2.25 gm